Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema (RUBY)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: REGN910-3; Drug: Intravitreal Aflibercept Injection (IAI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02712008

R910-3-DME-1518

Details and patient eligibility

About

The primary objective of the study was to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in participants with diabetic macular edema (DME).

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement in the study eye
2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Key Exclusion Criteria:

1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye
2. IVT anti-VEGF in the study eye within 12 weeks of the screening visit
3. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening

Note: Other inclusion/ exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 8 patient groups

REGN910-3 (3 mg: 2 mg)

Experimental group

Description:

Participants were administered intravitreal injection of REGN910-3 (3 milligram (mg):2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.

Treatment:

Drug: REGN910-3

REGN910-3 (6 mg:2 mg)

Experimental group

Description:

Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to week 12.

Treatment:

Drug: REGN910-3

Aflibercept 2 mg

Active Comparator group

Description:

Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)

REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8

Experimental group

Description:

Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 16 and Q8 through Week 32.

Treatment:

Drug: REGN910-3

REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12

Experimental group

Description:

Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 20 and Q12 through Week 32.

Treatment:

Drug: REGN910-3

Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8

Experimental group

Description:

Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week16 and Q8 through Week 32.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)

Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12

Experimental group

Description:

Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week 20 and Q12 through Week 32.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)

Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8

Experimental group

Description:

Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.

Treatment:

Drug: REGN910-3

Drug: Intravitreal Aflibercept Injection (IAI)